Oxytetracycline 250mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Oxytetracycline dihydrate

Disponible des:

Kent Pharma (UK) Ltd

Codi ATC:

J01AA06

Designació comuna internacional (DCI):

Oxytetracycline dihydrate

Dosis:

250mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05010300; GTIN: 5039290001089

Informació per a l'usuari

_Title:_
_Ref:_
_Date:_
_Size (mm):_
_Modified:_
Oxytetracycline 250mg PIL
D-OXY
25/09/20
297(H) x 148(W)
24/02/23
_Colours_
_(Printed)_
PROCESS
BLACK
_Colours_
_(Non printed)_
REFERENCE
CUTTER
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, please
ask your doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1.
What Oxytetracycline Tablets are and what
they are used for
2.
What you need to know before you take
Oxytetracycline Tablets
3.
How to take Oxytetracycline Tablets
4.
Possible side effects
5.
How to store Oxytetracycline Tablets
6.
Contents of the pack and other information
1. What Oxytetracycline Tablets are
and what they are used for
These tablets contain the active ingredient,
oxytetracycline. Oxytetracycline belongs to a
group of medicines called broad spectrum
antibiotics. This means that it is active against a
large number of bacteria which cause infections.
Oxytetracycline Tablets are used to treat a wide
range of infections caused by bacteria. They are
also used for preventing and treating chronic
bronchitis, severe acne, urinary tract (bladder and
kidney) infections and venereal diseases such as
syphillis and gonnorrhoea.
2. What you need to know before
you take Oxytetracycline Tablets
Do not take Oxytetracycline Tablets if:
•
You know you are allergic to Oxytetracycline
(or any other medicine belonging to the
tetracycline group of drugs) or you are allergic
to any of the other ingredients in this medicine
(these are listed in section 6)
•
You have long term kidney or liver dysfunction
•
You suffer from (SLE) systemic lupus
er

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oxytetracycline Tablets BP 250 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablets contains Oxytetracycline 250.0 mg (as dihydrate).
Excipients with known effect:
Lactose 13.44 mg
Sucrose 180 mg
Tartrazine (E102) approximately 0.24 mg.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Coated tablet.
Round, yellow, sugar coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of infections due to Chlamydia, Brucella, Mycoplasma,
Rickettsia,
and other sensitive organisms. May also be used for prophylaxis and
treatment of chronic bronchitis, non-gonococcal urethritis,
gonorrhoea,
syphilis, other urinary tract infections and severe acne vulgaris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The tablets should preferably be taken on an empty stomach (1 hour
before
food or 2 hours after).
Adults, the elderly and children over 12 years:
Normal dose is 250 – 500 mg every 6 hours (4 times a day). This may
be
increased in severe infections.
For acne the dose is usually 250 mg three times a day for 4 weeks, but
this
may be prolonged if necessary.
Children under 12 years of age: Not to be given.
Route of administration
For oral administration.
4.3
CONTRAINDICATIONS
Must not be given to children under 12 years.
Known hypersensitivity to the active substance or to any of the
excipients
listed in section 6.1.
Chronic renal or hepatic dysfunction.
Pregnancy or breastfeeding.
Systemic lupus erythematosus (SLE).
Patients receiving vitamin A or retinoid therapy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Tetracycline drugs may cause permanent tooth discoloration
(yellow-grey-
brown), if administered during tooth development, in the last half of
pregnancy and in infancy up to twelve years of age. Enamel hypoplasia
has
also been reported. This adverse reaction is more common during
long-term
use of the drug but has been observed following repeated short term
courses
The anti-anabolic action of tetracyclines m